Evaluation of tolerance, suckling and food intake after repeated nasals administrations of Oxytocin in PWS infants

Phase 1

• Conditions: Prader Willi Syndrom; MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-005325-67-FR
• Lead Sponsor: Centre Hospitalier de Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-25
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Infants with PWS genetically confirmed
Aged less than 5 months

Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Infants presenting hepatic insufficiency
Infants presenting renal insufficiency
Infants with abnormal ECG

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study tolerance oxytocin repeated nasal administrations during 7 days (according to 3 plans of administration) to babies with Prader Willi Syndrom younger than 5 months. ;Secondary Objective: •Preliminary study of efficacy on:<br>•suckling and swallowing and quantity of milk intake/day<br>•infant-mother interactions before during and after feeding <br>•weight gain and growth<br>•Pathophysiological study of <br>•cerebral metabolism (fMRI bold)<br>•plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism •Pharmacokinetic study à minima”: measurement of circulating oxytocin levels before administration and every 48hrs.<br>;Primary end point(s): Occurrence of adverse event, description and quantification of their severity, imputability to repeated intranasal administration of OT ;Timepoint(s) of evaluation of this end point: during 7 days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Preliminary study of efficacy on:<br>Suckling and swallowing and quantity of milk intake/day<br>Infant-mother interactions before during and after feeding <br>weight gain and growth<br>Pathophysiological study of <br>cerebral metabolism (fMRI bold)<br>plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism<br>Pharmacokinetic study à minima”: measurement of circulating oxytocin levels before administration and every 48hrs.;Timepoint(s) of evaluation of this end point: Before and during 7 days after OT admininistration.